| CTRI Number |
CTRI/2024/07/071047 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Neuron Specific Enolase in prognostication of Traumatic Brain Injury and Ischaemic Brain Injury |
|
Scientific Title of Study
|
Predicitve value of the brain biomarker Neuron Specific Enolase in prognostication of patients with Traumatic and Ischemic Brain Injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J M Ganshyam |
| Designation |
Director of Critical Care Medicine |
| Affiliation |
Medicover Hospitals |
| Address |
Department Of Critical Care medicine Medical ICU 3rd floor Medicover Hospital HITECH City Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9949001344 |
| Fax |
|
| Email |
drganshyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J M Ganshyam |
| Designation |
Director of Critical Care Medicine |
| Affiliation |
Medicover Hospitals |
| Address |
Department Of Critical Care Medicine Medical ICU 3rd floor Medicover Hospital HITECH City Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9949001344 |
| Fax |
|
| Email |
drganshyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kesireddy Venkata Kalyan |
| Designation |
Resident |
| Affiliation |
Medicover Hospitals |
| Address |
Department Of Critical Care Medicine Medical ICU 3rd floor Medicover Hospital HITECH City Hyderabad
Hyderabad
TELANGANA
500081
India |
| Phone |
9642149314 |
| Fax |
|
| Email |
kesireddykalyan96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicover Hospitals
HITEC City Hyderabad Telangana India 500081 |
|
|
Primary Sponsor
|
| Name |
Medicover Hospitals |
| Address |
Medical ICU 3rd floor Medicover Hospital HITEC City Hyderabad Telangana India 500081 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kesireddy Venkata Kalyan |
Medicover Hospitals |
Critical Care Department Medical ICU 3rd floor Medicover Hospitals HITECH City Hyderabad Telangana India 500081
Hyderabad
TELANGANA |
9642149314
kesireddykalyan96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Medicover Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G936||Cerebral edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients with TBI of moderate to severe grades as defined by BTF guidelines presenting with in 24hrs of injury
2 All patients with Acute Ischaemic Stroke with ASPECTS score less than 6
presenting with in 24hrs of symptoms |
|
| ExclusionCriteria |
| Details |
1 Age less than 18 years
2 Pregnancy
3 Recent Neurosurgery less than 12 weeks
4 No consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Predictive valu of Neuron Specific Enolase ICU mortality
in ICU |
At time of admission and after 24hrs of first sample |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GCOS at ICU discharge
Hospital Mortality
GCOS at hospital discharge
28 day Mortality
90 day Mortality |
At 28days , 90 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kesireddykalyan96@gmail.com].
- For how long will this data be available start date provided 30-07-2024 and end date provided 18-07-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Biomarkers are objective indicators used to assess normal or pathological processes, evaluate responses to treatment and predict outcomes Serum biomarkers were listed into the following broad categories for ease of discussion immune markers and markers of inflammation, hormones as biomarkers coagulation and vasculature genetic polymorphisms antioxidants and oxidative stress, apoptosis and degradation pathways and protein markers. Traumatic brain injury (TBI) and Stroke are responsible for the majority of neurology cause of death and are leading cause of disability . Outcome prognostication in ischemic stroke patients remains challenging due to limited predictive properties of existing models. Blood-based biomarkers might provide additional information to established prognostic factors. Glial fibrillary acidic protein (GFAP) S100, and neurons specific enolase (NSE) were the most prominent and frequently cited markers Aim of the study is to know the trends of NSE in Stroke and TBI . |